Sunrise Medical - FDA 510(k) Cleared Devices

Sunrise Medical, is a global mobility and seating solutions manufacturer headquartered in the United Kingdom, with a manufacturing facility in Somerset, US. Since 1983, the company has pioneered high-performance wheelchairs, powered mobility devices, and postural support systems. Sunrise Medical operates sales offices in 24 countries and distributes across 130 countries worldwide.

The company has received 14 FDA 510(k) clearances from 14 total submissions. Historically, 79% of submissions focused on Anesthesiology devices, including respiratory support systems, oxygen concentrators, and CPAP masks. The company's FDA 510(k) clearance activity spans from 2002 to 2013. This company is inactive-no clearances have been granted in more than 5 years and should be treated as a historical regulatory record.

Notable cleared devices include portable oxygen concentrators, bilevel CPAP systems, nasal masks, and oxygen cylinder filling systems. These products reflect the company's historical focus on respiratory and anesthesiology support technologies.

Explore the complete list of device names, product codes, and clearance dates in the database records below.

510(k) submissions have been managed by Entela, Inc. as regulatory consultant.